Health Law Daily Wrap Up, ENFORCEMENT ACTIONS—D. Minn.: Consent decree entered against Gold Star Distribution, Inc. following persistent insanitary warehouse conditions, (Sep 25, 2026)

By Donielle Tigay Stutland, J.D.

The court permanently enjoined the company from receiving or shipping FDA-regulated products until they eliminate pests and filth, repair the facility, and obtain written FDA approval to resume operations.

The U.S. District Court for the District of Minnesota entered a consent decree of permanent injunction against Gold Star Distribution, Inc. (Gold Star), a Minnesota-based multi-commodity warehouse operator, and its owner, Bassam Abu Samrah, after the FDA observed persistent insanitary conditions, including severe rodent and pest infestations, that put food, drugs, medical devices, and cosmetics at risk of potential contamination with filth. Gold Star operated a facility at 1000 Humboldt Avenue North, Minneapolis, Minnesota, and consented to the decree without contest and before any testimony (United States v. Gold Star Distribution, Inc., No. 26-cv-03976-LMP-ECW (D. Minn. Sept. 21, 2026)).

In 2025, the FDA and the Minnesota Department of Agriculture (MDA), in collaboration with other state regulatory partners including the Minnesota Board of Pharmacy, investigated persistent insanitary conditions at Gold Star’s warehouse facility in Minneapolis. The government alleges that Gold Star violated the Food, Drug, and Cosmetic Act (“the Act”), 21 U.S.C. § 331(k), by causing articles of food (including human and animal food, dietary supplements, and infant formula), drugs, devices, and cosmetics within the meaning of the Act, 21 U.S.C. § 321, that are held for sale after shipment of one or more of their components in interstate commerce to become adulterated within the meaning of 21 U.S.C. §§ 342(a)(4) (food), 351(a)(2)(A) (drugs and devices), and 361(c) (cosmetics), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health.

“Consumers trust that the products they purchase—whether food, medicine, or everyday household items—have been stored safely and are free from contamination,” said Elizabeth Miller, Pharm.D., FDA associate commissioner for inspections and investigations in a press release. “When a company repeatedly ignores serious, ongoing violations that put trust at risk, the FDA will act. This consent decree makes clear that persistent failure to maintain basic sanitary conditions is unacceptable and will have consequences.”

Complaint. The U.S. Department of Justice filed the complaint on behalf of the FDA, alleging that Gold Star and its principal violated the Act by causing food, drugs, medical devices, and cosmetics to become adulterated, while such products were held for sale in the Gold Star facility after shipment in interstate commerce, in that such products were held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. The complaint also stated that Gold Star and its principal violated the Act by causing drugs to become adulterated because such products were not stored in accordance with current good manufacturing practice requirements for drugs.

Consent Decree. The consent decree requires that Gold Star and all principals are permanently restrained from receiving, holding for sale, or distributing FDA-regulated products at or from the facility unless and until they satisfy detailed preconditions. These include:

• Retaining an independent, qualified expert (with no personal or financial ties to Defendants) to develop a written sanitation control program and drug storage control plan acceptable to FDA. The plans must address receiving, holding, and distribution practices; pest exclusion and monitoring; incoming product inspection; employee training; facility sanitation and repair; and drug CGMP requirements (including 21 C.F.R. §§ 211.56, 211.58, and 211.142 for temperature, humidity, light, and related storage conditions).

• FDA written approval of the plans.

• Retention of an independent pest-control company, comprehensive inspections until pests are eliminated, structural repairs (floors, walls, windows, doors, sewer system, and building), thorough cleaning, and documented verification (including photographs).

• An expert inspection verifying implementation, correction of prior FDA and MDA observations, and overall compliance, followed by FDA inspection(s) at Defendants’ expense; and

Gold Star must receive written notification from the FDA that they appear to be in compliance before resuming operations. The consent decree also provides that Gold Star must destroy, under FDA supervision and pursuant to an FDA-approved written plan, all FDA-regulated products in their custody as of the decree’s entry, within 60 calendar days, and bear all related costs.

The Case is No. 26-cv-03976-LMP-ECW.

Judge: Provinzino, L.

Attorneys: David Sullivan, U.S. Department of Justice, for the U.S.

Companies: Gold Star Distribution, Inc.

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